One form to get support with Orilissa® Complete
Give your clinically appropriate patients a free 28-day trial* of ORILISSA with Orilissa Complete
Help her enroll in Orilissa Complete to activate her free trial:
Download and complete this Enrollment & Prescription Form with your patient to access a 28-day trial supply, so she has the opportunity to try treatment for free.* Then, you can both decide if continuing ORILISSA is still the right choice for her.
Fax the form to 1-833-674-5477.
An Orilissa Complete Access Specialist will contact your office with next steps.
Give your patient the Patient Welcome Sheet.
Starting your patient on the free trial? We’ll call to confirm shipping details.
Savings and access support
One form gives your clinically appropriate patients access to everything Orilissa Complete has to offer:
Once enrolled, a free 28-day trial supply of ORILISSA will be shipped quickly, directly to her. Then, you can both decide if continuing on ORILISSA is still the right choice for her.
After the trial period, if your eligible commercially insured ORILISSA patient experiences an initial delay or denial of coverage, she may still be able to continue to access her prescribed therapy at no charge while coverage is established, for up to 24 months.†
The Orilissa Complete Savings Card can help your eligible commercially insured patients pay as little as $5 per month‡ for ORILISSA.
Access Specialists are an in-person and over-the-phone resource with expertise in options to consider based on each patient’s unique insurance coverage situation.
- They can educate on payer prior authorization (PA) and appeal processes so you can determine the best access solution
- They are a resource with expertise in insurance plan processes at a national, local, and program level
Orilissa Complete is here to help your patients get timely access to ORILISSA. Along with requesting information from an Orilissa Complete Access Specialist, you can download the forms your patients may need to get started.
Instructions are available to provide helpful tips and guidelines for completing the forms.
This information is for informational purposes only and is not intended to provide reimbursement or legal advice. The information presented here does not guarantee payment or coverage.
*The ORILISSA free trial provides a single 28-day trial supply of ORILISSA at no cost to new patients residing in the United States with a valid prescription for an FDA-approved indication of ORILISSA and who enroll in Orilissa Complete. The trial is intended solely to allow new patients not currently taking ORILISSA to determine with their healthcare provider whether ORILISSA is right for them. There is no obligation to continue use of ORILISSA after the trial has concluded and this program does not guarantee insurance coverage. Eligible patients are limited to one 28-day trial supply and may not re-enroll. The ORILISSA trial supply will be dispensed only through an AbbVie-authorized pharmacy to the patient’s home address and may not be sold or further distributed. No claims for payment may be submitted to any third party insurance plan for product dispensed by program. AbbVie reserves the right to change or discontinue the trial at any time without notice. The trial is not health insurance and is not a discount, coupon, rebate or financial assistance program. Limitations may apply.
†Program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be eligible to participate in program. Available to patients between the ages of 18-63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with endometriosis, have a valid prescription for ORILISSA, and participate in a commercial insurance plan that has denied or not yet made a formulary decision for ORILISSA. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for ORILISSA, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides ORILISSA at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance, and program does not guarantee insurance coverage.
‡Terms and Conditions apply. This benefit covers ORILISSA. Eligibility: Available to patients with commercial prescription insurance coverage for ORILISSA who meet eligibility criteria. Copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the Orilissa Complete Savings Card and patient must call Orilissa Complete at 1-800-ORILISSA (1-800-674-5477) and stop use of the copay card. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from Orilissa Complete including the copay card from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance.
Indication and Important Safety Information
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
IMPORTANT SAFETY INFORMATION1
- ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with known osteoporosis or severe hepatic impairment, or with concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil).
WARNINGS AND PRECAUTIONS
- ORILISSA causes a dose-dependent decrease in bone mineral density (BMD), which is greater with increasing duration of use and may not be completely reversible after stopping treatment.
- The impact of ORILISSA-associated decreases in BMD on long-term bone health and future fracture risk is unknown. Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss, and do not use in women with known osteoporosis.
- Limit the duration of use to reduce the extent of bone loss.
Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy
- Women who take ORILISSA may experience a reduction in the amount, intensity, or duration of menstrual bleeding, which may reduce the ability to recognize the occurrence of pregnancy in a timely manner. Perform pregnancy testing if pregnancy is suspected, and discontinue ORILISSA if pregnancy is confirmed.
Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders
- Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with ORILISSA in the endometriosis clinical trials.
- ORILISSA users had a higher incidence of depression and mood changes compared to placebo and ORILISSA users with a history of suicidality or depression had an increased incidence of depression. Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate.
- Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing ORILISSA if such events occur.
Hepatic Transaminase Elevations
- In clinical trials, dose-dependent elevations of serum alanine aminotransferase (ALT) at least 3 times the upper limit of the reference range occurred with ORILISSA.
- Use the lowest effective dose and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice.
- Promptly evaluate patients with elevations in liver tests to determine whether the benefits of continued therapy outweigh the risks.
Reduced Efficacy with Estrogen-Containing Contraceptives
- Based on the mechanism of action of ORILISSA, estrogen-containing contraceptives are expected to reduce the efficacy of ORILISSA. The effect of progestin-only contraceptives on the efficacy of ORILISSA is unknown.
- Advise women to use non-hormonal contraceptives during treatment and for one week after discontinuing ORILISSA.
- The most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, and mood changes.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in patients less than 18 years of age have not been established.
For more information, please click here for full Prescribing Information.
1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc.